NCT07156305

Brief Summary

The primary goal of this clinical trial is to examine whether the use of personalized goal setting related to protective behavioral strategies (PBS)-behavioral techniques enacted before, during, or after alcohol consumption to reduce risk and minimize harm-increases the use of personally selected PBS implementation. A secondary goal of this trial is to examine whether increasing the frequency of PBS use will lead to decreases in alcohol consumption, fewer alcohol-related negative consequences, and increased alcohol-related positive consequences. Researchers will compare a control condition, a PBS-only condition, and a PBS+Goals condition to address the aims of the study. Participants in all conditions will complete measures about current PBS use, alcohol use and consequences, and likelihood and confidence to change current alcohol and strategy use. All participants will receive brief psychoeducation on PBS. Participants in the PBS-only and PBS+Goals condition will select three PBS to use over the following two weeks, and select a strategy for remembering the PBS they chose. Participants in the PBS+Goals condition will receive psychoeducation about goal setting and identify two goals related to each PBS strategy they selected. Participants in all conditions will complete a follow-up after two weeks containing measures about PBS use, alcohol use and consequences, and likelihood and confidence to change alcohol and strategy use. Participants in the PBS-only and PBS+Goals condition will complete a measure to indicate whether they used the reminder strategy they selected at the two-week follow-up. Participants in the PBS+Goals condition will complete a measure indicating whether they believe they achieved their goals at the two-week follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Sep 2025May 2027

First Submitted

Initial submission to the registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

August 26, 2025

Last Update Submit

April 27, 2026

Conditions

Alcohol Use

Keywords

Protective behavioral strategyPBSProtective behavioral strategiesAlcohol useAlcohol consequences

Outcome Measures

Primary Outcomes (4)

  • Protective Behavioral Strategy Use

    Participants will be asked at baseline and follow-up to indicate the frequency they use the various PBS included in the Protective Behavioral Strategies Scale - 20 (PBSS-20) across the past two weeks. Change will be examined across groups as the mean change in past-two-week frequency of PBS use at follow-up relative to baseline.

    Baseline and two-week follow-up.

  • Alcohol Use

    Participants will be asked to complete the Timeline Follow-Back (TLFB), a measure of past-two-week alcohol use, at baseline and follow-up. Change will be examined across groups as mean change in past-two-week alcohol use at at follow-up relative to baseline.

    Baseline and two-week follow-up

  • Negative Alcohol-Related Consequences

    Participants will be asked to report on the total number of negative alcohol-related consequences they have experienced in the past two weeks using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). Change will be examined across group as the mean change in number of negative alcohol-related consequences experienced across the past two weeks at follow-up relative to baseline.

    Baseline and two-week follow-up

  • Positive Alcohol-Related Consequences

    Participants will be asked to report on the number of positive alcohol-related consequences they have experienced across the past two weeks at baseline and follow-up using the Positive Drinking Consequences Questionnaire (PDCQ). Change across groups will be examined as the mean change in number of positive alcohol-related consequences at follow-up relative to baseline.

    Baseline and two-week follow-up

Secondary Outcomes (2)

  • Likelihood to Change

    Baseline and two-week follow-up

  • Confidence in Changing

    Baseline and two-week-follow-up

Study Arms (3)

Control

NO INTERVENTION

Participants complete measures at baseline and follow-up, and receive psychoeducation on PBS.

PBS-only

ACTIVE COMPARATOR

Participants complete measures at baseline and follow-up, receive psychoeducation about PBS, select three PBS strategies, and select a reminder strategy.

Behavioral: Protective Behavioral Strategies

PBS+Goals

EXPERIMENTAL

Participants complete measures at baseline and follow-up, receive psychoeducation about PBS and goal-setting, select three PBS strategies, select two goals related to each PBS strategy chosen, and select a reminder strategy.

Behavioral: Goal-Setting

Interventions

Protective Behavioral StrategiesBEHAVIORAL

Participants receive psychoeducation about protective behavioral strategies and are asked to choose three strategies that they do not already engage in regularly but would be willing to start using more.

PBS-only
Goal-SettingBEHAVIORAL

Participants receive psychoeducation about protective behavioral strategies and goal-setting. They are asked to choose three strategies that they do not already engage in regularly and identify two goals related to each strategy.

PBS+Goals

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must report being between the ages of 18-25
  • Must report engaging in alcohol use at least one time per week over the past two weeks, on average

You may not qualify if:

  • Reports currently receiving or having received treatment for their alcohol or other substance use during the past two months
  • Age below 18 or above 25 years
  • Does not report having engaged in alcohol use at least one time per week over the past two weeks, on average

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82072, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Organizational Objectives

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Central Study Contacts

Anna M Petrey, BS

CONTACT

307-314-2111apetrey@uwyo.edu

Alison Looby, PhD

CONTACT

alooby@uwyo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology Doctoral Student

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 5, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)